NEW YORK – Invivoscribe announced Thursday that its test for FLT3 mutations in patients with leukemia has achieved regulatory compliance in the UK and Switzerland.
The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3 mutations, which are associated with poor prognosis in patients with acute myeloid leukemia and can help guide targeted therapy options. The test gained regulatory compliance through Invivoscribe's UK Responsible Person and Swiss Authorized Representative, "ensuring full adherence to national regulatory frameworks," the company said in a statement.
The UK Responsible Person acts on behalf of a non-UK manufacturer to carry out specific tasks related to the manufacturer's obligations, such as registering the manufacturer's devices with the Medicines and Healthcare Products Regulatory Agency (MHRA).
The Swiss Authorized Representative receives and accepts a written mandate from a manufacturer located in another country to act on the manufacturer's behalf for specified tasks. If a manufacturer is not established in Switzerland, its devices can only be put on the market once an authorized representative established in Switzerland has been designated.
Both the MHRA and Swissmedic in Switzerland have officially registered the assay, said Invivoscribe, a San Diego-based developer of precision diagnostics.
The PCR-based test detects internal tandem duplication (ITD) and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in DNA extracted from mononuclear cells that were obtained from peripheral blood or bone marrow aspirates. It may be used as a companion diagnostic to assess patients who might be eligible for treatment with Astellas Pharma's Xospata (gilteritinib fumarate) and Daiichi Sankyo's Vanflyta (quizartinib hydrochloride) in regions where those drugs are available.
The assay runs on Thermo Fisher Scientific's 3500xL or 3500xL Dx Genetic Analyzers.
The test was CE marked and approved by the European Medicines Agency as a companion diagnostic for Vanflyta in patients with newly diagnosed FLT3-ITD-positive acute myelogenous leukemia last year. It was approved by the US Food and Drug Administration for selecting Vanflyta-eligible patients and approved under Europe's In Vitro Diagnostic Regulation in 2023.